Vimovo Patent Expiration

Vimovo is a drug owned by Horizon Medicines Llc. It is protected by 22 US drug patents filed from 2013 to 2017. Out of these, 3 drug patents are active and 19 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 17, 2031. Details of Vimovo's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6875872 Compounds
May, 2014

(10 years ago)

Expired
US6875872

(Pediatric)

Compounds
Nov, 2014

(9 years ago)

Expired
US5714504 Compositions
Feb, 2015

(9 years ago)

Expired
US5714504

(Pediatric)

Compositions
Aug, 2015

(8 years ago)

Expired
US5900424 Omeprazole magnesium salt form
May, 2016

(8 years ago)

Expired
US5900424

(Pediatric)

Omeprazole magnesium salt form
Nov, 2016

(7 years ago)

Expired
US7411070 Form of S-omeprazole
May, 2018

(6 years ago)

Expired
US6369085 Form of S-omeprazole
May, 2018

(6 years ago)

Expired
US7745466 Form of S-omeprazole
Oct, 2018

(5 years ago)

Expired
US7411070

(Pediatric)

Form of S-omeprazole
Nov, 2018

(5 years ago)

Expired
US6369085

(Pediatric)

Form of S-omeprazole
Nov, 2018

(5 years ago)

Expired
US9345695 Pharmaceutical compositions for the coordinated delivery of NSAIDs
May, 2022

(2 years ago)

Expired
US8858996 Pharmaceutical compositions for the coordinated delivery of NSAIDS
May, 2022

(2 years ago)

Expired
US8852636 Pharmaceutical compositions for the coordinated delivery of NSAIDs
May, 2022

(2 years ago)

Expired
US8557285 Pharmaceutical compositions for the coordinated delivery of NSAIDs
May, 2022

(2 years ago)

Expired
US9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs
May, 2022

(2 years ago)

Expired
US9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs
May, 2022

(2 years ago)

Expired
US9707181 Pharmaceutical compositions for the coordinated delivery of NSAIDs
May, 2022

(2 years ago)

Expired
US6926907 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Feb, 2023

(1 year, 4 months ago)

Expired
US9393208 Method for delivering a pharmaceutical composition to patient in need thereof
Sep, 2029

(5 years from now)

Active
US9220698 Method for delivering a pharmaceutical composition to patient in need thereof
Mar, 2031

(6 years from now)

Active
US8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer
Oct, 2031

(7 years from now)

Active


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Vimovo and ongoing litigations to help you estimate the early arrival of Vimovo generic.

Vimovo's Litigations

Vimovo has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 21, 2015, against patent number US6926907. The petitioner Coalition for Affordable Drugs VII LLC, challenged the validity or infringement of this patent, with POZEN Inc. as the respondent. Click below to track the latest information on how companies are challenging Vimovo's patents.


Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9393208 July, 2018 Terminated-Other Pozen Inc. Dr. Reddy's Lab., Inc.
US9220698 April, 2018 FWD Entered Horizon Pharma USA, Inc. Dr. Reddy's Laboratories, Inc.
US9393208 December, 2017 FWD Entered Horizon Pharma USA, Inc. Mylan Pharmaceuticals Inc.
US9220698 August, 2017 Terminated-Other Horizon Pharma USA, Inc. Mylan Pharmaceuticals Inc.
US8852636 August, 2015 Terminated-Denied Pozen Inc. Lupin Pharmaceuticals Inc
US8858996 August, 2015 FWD Entered Pozen Inc. Lupin Pharmaceuticals Inc.
US8945621 August, 2015 FWD Entered Pozen Inc Coalition for Affordable Drugs VII LLC
US8852636 August, 2015 Terminated-Denied Pozen Inc. Coalition for Affordable Drugs VII LLC
US8858996 June, 2015 Terminated-Denied Pozen Inc. Coalition for Affordable Drugs VII LLC
US6926907 May, 2015 Terminated-Denied POZEN Inc. Coalition for Affordable Drugs VII LLC


FDA has granted some exclusivities to Vimovo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vimovo, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Vimovo.

Exclusivity Information

Vimovo holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Vimovo's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Combination(NC) Apr 30, 2013
New Patient Population(NPP) Jul 06, 2020

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Several oppositions have been filed on Vimovo's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Vimovo's generic, the next section provides detailed information on ongoing and past EP oppositions related to Vimovo patents.

Vimovo's oppositions filed in EPO

Vimovo has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 15, 2011, by Strawman Limited. This opposition was filed on patent number EP02734602A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP02734602A Apr, 2011 CHATFIELD PHARMACEUTICALS LIMITED Patent maintained as amended
EP02734602A Apr, 2011 STRAWMAN LIMITED Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Vimovo is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Vimovo's family patents as well as insights into ongoing legal events on those patents.

Vimovo's family patents

Vimovo has patent protection in a total of 26 countries. It's US patent count contributes only to 35.6% of its total global patent coverage. 14 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Vimovo.

Family Patents

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Generic Launch

Generic Release Date:

Vimovo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 17, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Vimovo Generics:

Esomeprazole Magnesium; Naproxen is the generic name for the brand Vimovo. 6 different companies have already filed for the generic of Vimovo, with Actavis Labs Fl Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vimovo's generic

How can I launch a generic of Vimovo before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Vimovo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vimovo's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Vimovo -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
375 mg/20 mg and 500 mg/20 mg 05 Nov, 2010 1 28 Feb, 2023 Extinguished




About Vimovo

Vimovo is a drug owned by Horizon Medicines Llc. It is used for relieving symptoms of arthritis and reducing the risk of NSAID-associated gastric ulcers. Vimovo uses Esomeprazole Magnesium; Naproxen as an active ingredient. Vimovo was launched by Horizon in 2010.

Market Authorisation Date:

Vimovo was approved by FDA for market use on 30 April, 2010.

Active Ingredient:

Vimovo uses Esomeprazole Magnesium; Naproxen as the active ingredient. Check out other Drugs and Companies using Esomeprazole Magnesium; Naproxen ingredient

Treatment:

Vimovo is used for relieving symptoms of arthritis and reducing the risk of NSAID-associated gastric ulcers.

Dosage:

Vimovo is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, DELAYED RELEASE Discontinued ORAL
EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, DELAYED RELEASE Discontinued ORAL